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MedImmune initiates MEDI8897 phase I clinical studies for treatment of RSV infections

AIMM Therapeutics, a leading human therapeutic antibody company, today announced that its partner MedImmune, LLC, the global biologics unit of AstraZeneca, has initiated phase I clinical studies with MEDI8897, a best-in-class antibody for the treatment of respiratory syncytial virus (RSV) infections in young, at risk children.

2 Jul 2014

Prophage autologous cancer vaccine extends survival in patients with newly diagnosed GBM

Agenus Inc., announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus' Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected.

1 Jul 2014

CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

CTI BioPharma Corp. announced today that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of myelofibrosis.

From Baxter International Inc. 1 Jul 2014

Aclaris Therapeutics reports positive results from A-101 Phase 2 trial for removing SK lesions

Aclaris Therapeutics, Inc. today announced positive results from a Phase 2 clinical trial of the Company's lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing seborrheic keratoses (SK), one of the most common types of skin tumors.

1 Jul 2014

UCSF researchers complete first Internet-based clinical trial for children with autism

UC San Francisco researchers have completed the first Internet-based clinical trial for children with autism, establishing it as a viable and cost effective method of conducting high-quality and rapid clinical trials in this population.

1 Jul 2014

BioLight enrolls first patient in FDA Phase 1/2a clinical trial with Eye-D for treatment of glaucoma

BioLight Israeli Life Sciences Investments Ltd., a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that the first patient has been enrolled in the U.S. into a FDA Phase 1/2a clinical trial with Eye-D, the company's controlled-release latanoprost insert for the treatment of glaucoma.

1 Jul 2014

Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Merck, known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

30 Jun 2014

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

30 Jun 2014

Synthetic Biologics supports SYN-004 C.difficile preventative program with formation of Clinical Advisory Board

Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today the formation of a Clinical Advisory Board (CAB) to support development of SYN-004, the Company's lead anti-infective product candidate for the prevention of the devastating effects of Clostridium difficile (C. difficile)

30 Jun 2014

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma.

30 Jun 2014

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Genervon Biopharmaceuticals LLC ("Genervon") today announced that it has analyzed and generated a Biomarker Data Report for its recent Phase 2a clinical trial for ALS disease modification.

30 Jun 2014

Conventional fertility hormones do not increase risk of breast, gynecological cancers

There is "little evidence" that the use of conventional fertility hormones used for ovarian stimulation in the treatment of infertility increases the long-term risk of breast and gynecological cancers, according to the results of a substantial 30-year follow-up study.

30 Jun 2014

Phase III TAS-102 study for metastatic colorectal cancer shows improved survival

The new combination agent TAS-102 is able to improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

30 Jun 2014

Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug.

28 Jun 2014

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014.

28 Jun 2014

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

Essentialis announced today the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients.

27 Jun 2014

ASPIRE completes patient enrollment in Phase III trial of vaginal ring for HIV prevention

ASPIRE, one of two Phase III trials of a promising method for preventing HIV in women - a vaginal ring worn for a month at a time - has completed enrollment of participants, with 2,629 women from 15 clinical research sites in Malawi, South Africa, Uganda and Zimbabwe now taking part in the study.

27 Jun 2014

Scientists report first successful step toward vaccine that targets mutation in brain cancer

Astrocytomas and oligodendrogliomas are subtypes of a brain cancer called 'glioma'. These incurable brain tumors arise from glial cells, a type of support cell found in the central nervous system.

26 Jun 2014

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on revolutionizing the treatment of cancer through the targeted delivery of therapeutic agents directly to cancer cells, today announced plans to move forward with a Phase 2a clinical trial in the U.S. using its formulation of EGFR-targeted, EDV nanocells packaged with doxorubicin for the treatment of recurrent glioblastoma (GBM), a common and aggressive type of brain tumor.

26 Jun 2014

Adding MM-398 to standard treatment improves survival in metastatic pancreatic cancer patients

Adding the novel MM-398 to standard treatment for metastatic pancreatic cancer patients who have already received gemcitabine improves survival, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

26 Jun 2014

Drug Trial News

MedImmune initiates MEDI8897 phase I clinical studies for treatment of RSV infections

Prophage autologous cancer vaccine extends survival in patients with newly diagnosed GBM

CTI completes recruitment in PERSIST-1 clinical trial of pacritinib for treatment of myelofibrosis

Aclaris Therapeutics reports positive results from A-101 Phase 2 trial for removing SK lesions

UCSF researchers complete first Internet-based clinical trial for children with autism

BioLight enrolls first patient in FDA Phase 1/2a clinical trial with Eye-D for treatment of glaucoma

Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Synthetic Biologics supports SYN-004 C.difficile preventative program with formation of Clinical Advisory Board

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Conventional fertility hormones do not increase risk of breast, gynecological cancers

Phase III TAS-102 study for metastatic colorectal cancer shows improved survival

Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

ASPIRE completes patient enrollment in Phase III trial of vaginal ring for HIV prevention

Scientists report first successful step toward vaccine that targets mutation in brain cancer

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

Adding MM-398 to standard treatment improves survival in metastatic pancreatic cancer patients

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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